Research Personnel FAQs

You can add and remove personnel from your study on the personnel page in HSERA. Follow the instructions for submitting a modification to the IRB. When adding personnel, ensure they have completed required CITI training. For paper studies, ensure you email the personnel’s training certificate along with the request to add them to the study.

• For greater than minimal risk research, only faculty members may serve as the principal investigator on a study.
• For student / trainee (e.g., medical residents, non-faculty fellows) research, only faculty members may serve as the principal investigator on a study. The student may be listed as Co-Investigator in HSERA.
• Exceptions to faculty serving as the principal investigator may be made for minimal risk research. However, the principal investigator must still be a University or Penn Medicine employee.
• Other exceptions may be made on rare occasions and are considered by the IRB Director during the IRB review process. To request an exception, include a cover letter outlining the request along with a resume or CV with demonstrated expertise in conducting human subjects’ research.

Any research personnel who meet the DHHS definition of being engaged in research must be listed in HSERA on the personnel page. Generally, this will include anyone interacting or intervening with participants for research purposes. It also includes those involved in the consent process and anyone who has access to identifiable (including coded) participant information. There are exceptions outlined in the DHHS guidance. The Engaged in Research Determination Form can provide a guide for determining when someone is engaged in human subjects’ research.

DHHS Engaged in Research Guidance Engaged in Research Determination Form

There are a number of considerations when deciding whether to add an external investigator to a study.

• Will the external investigator be engaged in human subjects’ research as defined by DHHS? See linked guidance under Who should be listed on the personnel page in HSERA for more information on engagement in research. If the investigator is not engaged in human subjects’ research, they do not need to be added to the study.
• If the external investigator is engaged in human subjects’ research, are they engaged in the research as part of their duties at their home institution? If not, it may be appropriate to add them to the study under Penn via an Individual Investigator Agreement. Click below to learn more about Individual Investigator Agreements. If the external investigator is engaged in the research as part of their duties at their home institution, they should consult with their institutional IRB about submission requirements. A reliance agreement may be an appropriate option for research that does not fall into one of the 8 exempt categories of human subjects’ research.

IRB Reliance Agreements